Press Release – Expanded Access Program

2010 December 23
by Jason Yeh

The Abigail Alliance for Better Access to Developmental Drugs is happy to announce that there is now an expanded access program for the efficacious developmental metastatic melanoma drug PLX4032 (also known as RG7204 and RO5185426).   Information regarding the program can be found on clinicatrials.gov at:   http://www.clinicaltrials.gov/ct2/results?term=ml25597 , or by going to www.clinicaltrials.gov and searching for RO5185426.

The Abigail Alliance commends the sponsors Hoffmann-La Roche, its subsidiary Genentech, and Plexxikon for providing access to their breakthrough drug for the thousands of people diagnosed with metastatic melanoma who are, at this moment, fighting for their lives.

The Abigail Alliance has been communicating with the FDA and the sponsors with regard to this drug on behalf of patients.  Among our several recommendations, we have pressed both organizations to open an expanded access program for PLX4032 as soon as possible.  Please visit our website to learn more about our efforts to help people with metastatic melanoma gain access to PLX4032.

It should be noted that an unethical randomized trial that subjects terminal melanoma cancer patients to treatment with an old toxic drug in the control arm of a randomized trial (BRIM3 trial) is ongoing.  The Abigail Alliance continues to urge the FDA and the sponsors to find an alternative to  placing dying patients into a meaningless randomized trial control arm for no  other purpose than to satisfy a rigid and ill-fitting regulatory policy, and  move this drug toward approval as quickly as possible.  This drug already solidly meets the Congressional and FDA standards for Accelerated Approval. The patients enrolled in the control arm of the trial are being denied their chance to benefit from this new breakthrough drug, and under the rules of the trial, will be allowed to die without ever being offered this breakthrough drug.  The trial should be immediately stopped, and the control arm patients offered the new drug.

Frank Burroughs, President              703-646-5306
Steve Walker, Cofounder                    813-340-3193

Abigail Alliance for Better Access to Developmental Drugs
www.abigail-alliance.org
703-646-5306

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